FDA Adds Warning of Intestinal Blockages to Ozempic Label

Sept. 28, 2023 – Following more than a dozen reports of intestinal blockages among people using the diabetes drug Ozempic, the FDA announced that the potentially life-threatening condition will be listed on the drug’s label.

The medical term for intestinal blockage is “ileus,” and 18 cases of it in people taking Ozempic have been reported to the FDA. 

The FDA has received more than 8,500 reports of gastrointestinal issues among people taking medications like Ozempic and Wegovy, the latter of which is approved for weight loss. Ileus is mentioned in 33 cases, including two deaths, of people taking drugs containing semaglutide, which is the active ingredient in Ozempic, Wegovy, and another widely used weight loss drug called Mounjaro. 

Semaglutide works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that targets brain regions that regulate appetite and food intake. The labels for Mounjaro, Ozempic, and Wegovy already mention that delayed stomach emptying can occur. Significant weight loss is associated with taking semaglutide, often in the range of 15% of body weight.

The FDA stopped short of saying there is a direct link between Ozempic and intestinal blockages.

“Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure,” the FDA said in its approval of the label update.

The same warning for the risk of intestinal blockages is already listed on the labels for Mounjaro and Wegovy.

The label change comes after a Louisiana woman filed a lawsuit in August that claims she was “severely injured” after using Mounjaro and Ozempic and that the pharmaceutical companies failed to disclose the drugs’ risk of causing vomiting and diarrhea due to inflammation of the stomach lining, as well as the risk of stomach paralysis (known as gastroparesis.)